Daiichi Sankyo Files New Drug Application for DS-8201 in Japan

Daiichi Sankyo Files New Drug Application for DS-8201 in Japan
Daiichi Sankyo has submitted an application to Japanese regulatory authorities asking that its investigational therapy trastuzumab deruxtecan (DS-8201) be approved as a treatment for people with HER2-positive metastatic breast cancer. The New Drug Application (NDA) is based on results from the multi-center, randomized, open-label DESTINY-Breast01 Phase 2 trial (NCT03248492) and a previous Phase 1 clinical trial (NCT02564900). The Phase 1 trial tested DS-8201 in people with different types of HER2-positive cancers, including 115 women with HER2-positive breast cancer. Results showed that patients with metastatic breast cancer who had progressed after treatment with anti-HER2 therapies such as Kadcyla responded particularly well to the treatment. Tumors shrank at least partially in 60% of these patients, and 90% of patients achieved at least stable disease. The treatment did not cause significant side effects. The ongoing Phase 2 DESTINY-Breast01 trial is testing DS-8201 in 253 patients with inoperable and/or metastatic HER2-positive breast cancer, recruite
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